Martin Reck1, Kostas Syrigos2, Skaidrius Miliauskas3, Sabine Zöchbauer-Müller4, Jürgen R Fischer5, Hannes Buchner6, Thomas Kitzing7, Rolf Kaiser8, Dejan Radonjic9, Keith Kerr10. 1. Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), German Center of Lung Research (DZL), Wöhrendamm 80, 22927, Grosshansdorf, Germany. Electronic address: M.Reck@lungenclinic.de. 2. National and Kapodistrian University of Athens, Sotiria General Hospital, Mesogion 152, Athens 115 27, Greece. Electronic address: ksyrigos@med.uoa.gr. 3. Lithuanian University of Health Sciences, Department of Pulmonology, Medical Academy, Kaunas, A. Mickevičiaus g. 9, Kaunas 44307, Lithuania. Electronic address: Skaidrius.Miliauskas@kaunoklinikos.lt. 4. Medical University of Vienna, Department of Medicine I, Währinger Gürtel 18-20, 1090 Vienna, Austria. Electronic address: sabine.zoechbauer-mueller@meduniwien.ac.at. 5. Department of Oncology, Lungenklinik Löwenstein, D-74245 Löwenstein, Germany. Electronic address: juergen.fischer@klinik-loewenstein.de. 6. Staburo GmbH, Munich, Germany. Electronic address: hannes.buchner.ext@boehringer-dingelheim.com. 7. Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173 D-55216 Ingelheim am Rhein, Germany. Electronic address: thomas.kitzing@boehringer-ingelheim.com. 8. Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173 D-55216 Ingelheim am Rhein, Institute of Pharmacology, Johannes Gutenberg-University Mainz, Saarstraße 21, 55122 Mainz, Germany. Electronic address: rolf.kaiser@boehringer-ingelheim.com. 9. Boehringer Ingelheim International GmbH, Binger Straße 173 D-55216 Ingelheim am Rhein, Germany. Electronic address: dejan.radonjic@boehringer-ingelheim.com. 10. Department of Pathology, Aberdeen Royal Infirmary, Foresterhill Rd, Aberdeen AB25 2ZN, United Kingdom. Electronic address: k.kerr@abdn.ac.uk.
Abstract
OBJECTIVES: To evaluate the effectiveness and safety of nintedanib plus docetaxel in patients with advanced adenocarcinoma non-small cell lung cancer (NSCLC) previously treated with both chemo- and immunotherapy. MATERIALS AND METHODS: LUME-BioNIS is a European, prospective, multicenter, non-interventional study of patients with advanced adenocarcinoma NSCLC, who initiated nintedanib plus docetaxel after first-line chemotherapy in routine practice according to the approved nintedanib EU label. The primary objective is to explore whether molecular biomarkers can predict overall survival (OS). Information on clinical or radiologic progression and death, and adverse drug reactions (ADRs)/fatal adverse events (AEs) was collected during follow-up. Here, we report a subgroup analysis evaluating outcomes in immunotherapy-pretreated patients. RESULTS: Of 260 enrolled patients, 67 (25.8%) had prior immunotherapy and were included in this subgroup analysis. Prior immunotherapy was administered in first-line in 20 patients (29.9%; combined with chemotherapy in 4 patients [6.0%]) and later-lines in 47 patients (70.1%), and most commonly comprised nivolumab (39 patients; 58.2%), atezolizumab (14 patients; 20.9%) and pembrolizumab (11 patients; 16.4%). Nintedanib plus docetaxel was given in second-line in 10 patients (14.9%) and in later-lines in 57 patients (85.1%). Median OS was 8.8 months (95% confidence interval [CI]: 7.0-11.5) and median progression-free survival (PFS) was 4.6 months (95% CI: 3.5-5.7). Among 55 patients with available data, rates of objective response and disease control were 18.2% and 78.2%, respectively. In 65 patients evaluable for safety, the most common on-treatment ADRs/AEs were malignant neoplasm progression (19 patients; 29.2%), diarrhea (21 patients; 32.3%) and nausea (10 patients; 15.4%). CONCLUSIONS: Used according to the approved nintedanib label in routine practice, nintedanib plus docetaxel demonstrated clinical effectiveness, with no unexpected safety findings, in patients with prior chemotherapy and first- or later-line immunotherapy. These data add to the real-world evidence that can inform clinical decisions in the changing therapeutic landscape.
OBJECTIVES: To evaluate the effectiveness and safety of nintedanib plus docetaxel in patients with advanced adenocarcinoma non-small cell lung cancer (NSCLC) previously treated with both chemo- and immunotherapy. MATERIALS AND METHODS: LUME-BioNIS is a European, prospective, multicenter, non-interventional study of patients with advanced adenocarcinoma NSCLC, who initiated nintedanib plus docetaxel after first-line chemotherapy in routine practice according to the approved nintedanib EU label. The primary objective is to explore whether molecular biomarkers can predict overall survival (OS). Information on clinical or radiologic progression and death, and adverse drug reactions (ADRs)/fatal adverse events (AEs) was collected during follow-up. Here, we report a subgroup analysis evaluating outcomes in immunotherapy-pretreated patients. RESULTS: Of 260 enrolled patients, 67 (25.8%) had prior immunotherapy and were included in this subgroup analysis. Prior immunotherapy was administered in first-line in 20 patients (29.9%; combined with chemotherapy in 4 patients [6.0%]) and later-lines in 47 patients (70.1%), and most commonly comprised nivolumab (39 patients; 58.2%), atezolizumab (14 patients; 20.9%) and pembrolizumab (11 patients; 16.4%). Nintedanib plus docetaxel was given in second-line in 10 patients (14.9%) and in later-lines in 57 patients (85.1%). Median OS was 8.8 months (95% confidence interval [CI]: 7.0-11.5) and median progression-free survival (PFS) was 4.6 months (95% CI: 3.5-5.7). Among 55 patients with available data, rates of objective response and disease control were 18.2% and 78.2%, respectively. In 65 patients evaluable for safety, the most common on-treatment ADRs/AEs were malignant neoplasm progression (19 patients; 29.2%), diarrhea (21 patients; 32.3%) and nausea (10 patients; 15.4%). CONCLUSIONS: Used according to the approved nintedanib label in routine practice, nintedanib plus docetaxel demonstrated clinical effectiveness, with no unexpected safety findings, in patients with prior chemotherapy and first- or later-line immunotherapy. These data add to the real-world evidence that can inform clinical decisions in the changing therapeutic landscape.
Authors: Junjun Li; Yongchang Zhang; Li Wang; Min Li; Jianbo Yang; Pan Chen; Jie Zhu; Xiayu Li; Zhaoyang Zeng; Guiyuan Li; Wei Xiong; James B McCarthy; Bo Xiang; Mei Yi Journal: Cell Death Dis Date: 2022-08-16 Impact factor: 9.685